Expired Study
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Beltsville, Maryland 20705


Purpose:

The study will determine the effects of different types of soybean oils on biomarkers of risk for cardiovascular disease and diabetes. There will be four 4-week diet periods in which participants will consume the following oils, within the context of a controlled diet: soybean oil, high-oleic soybean oil, blend of high oleic soybean oil & fully hydrogenated soybean oil, and blend of palm olein & palm stearin.


Criteria:

Inclusion Criteria: - Age 30 to 70 years at beginning of study - LDL-cholesterol between 120 and 160 mg/dl - Less than 2+ risk factors for coronary heart disease (risk factors include: blood pressure > 140/90 mm Hg or on blood pressure medication; HDL-cholesterol < 40 mg/dl; age greater than 45 yrs for males & greater than 55 yrs for females; family history of premature coronary heart disease (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years) Exclusion Criteria: - Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes - Use of prescription or over-the-counter medications or supplements that alter lipid metabolism. - Women who have given birth during the previous 12 months - Pregnant women or women who plan to become pregnant or become pregnant during the study - Lactating women - Type 2 diabetes requiring the use of oral antidiabetic agents or insulin - History of bariatric or certain other surgeries related to weight control - Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity - Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study - Smokers or other tobacco users (during 6 months prior to the start of the study) - History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) - Known (self-reported) allergy or adverse reaction to study foods - Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months) - Unable or unwilling to give informed consent or communicate with study staff - Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion) - Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol


NCT ID:

NCT02404207


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Beltsville, Maryland 20705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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